HydroPICC Catheters Recalled for Incorrect Expiration Date Labeling
Access Vascular, Inc is recalling HydroPICC 4Fr Single Lumen catheters (Model 80001001) due to incorrect expiration date labeling. The devices expire earlier than the labeled date.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This recall is classified as Moderate severity. The devices are subject to FDA Class II classification, but no reported injuries or hospitalizations have been documented. The issue is incorrect expiration date labeling, which is a labeling error rather than a structural defect in the catheter itself.
Plain-English summary
Access Vascular, Inc has recalled HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit (Model Number 80001001) due to incorrect expiration date labeling. Select catheter lots were labeled with expiration dates that are later than the actual expiration date of the devices.
The recall affects 302 HydroPICC devices distributed nationwide to healthcare facilities in Connecticut, Illinois, Indiana, Massachusetts, Nebraska, Tennessee, and Texas. Affected lot numbers are 11398679 and 11416178.
Using expired catheters could result in device malfunction or reduced performance during medical procedures. Healthcare providers and facilities should immediately stop using any remaining units from the recalled lots and dispose of them according to medical waste procedures.
For more information, healthcare providers should contact Access Vascular, Inc through the FDA at the recall reference number Z-1131-2023.
The recalled product
- Product
- HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
- Manufacturer
- Access Vascular, Inc
- Hazard
- mis-labeling
- expired-device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: (01)00862559000456
- Lot Number: 11398679
- 11416178
Distribution
Distributed nationwide across the United States.
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